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Financial and business risk is unavoidable because there is risk in anything you do, including -- and especially -- doing nothing.

T

According to USFDA, a combination product is one composed of any combination of a drug and device; biological product and device; drug and biological product

here's market risk -- the risk that adverse market moves will cause you to lose money.

There's opportunity cost risk -- the risk tha

; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.

Examples of combination products may in

t you let a great opportunity pass you by.

There's interest rate risk -- the risk that you will try to be "conservative" by investin

lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.

for income only to see interest rates go much higher while you're locked in at a much lower rate.

There's inflation risk -- the ris

here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe

k that your investments will loose value over time due to the loss of purchasing power.

There's business risk -- the risk that you w

d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.

Combination pro

ill lose money in a business.

So choose your poison. Choose the kind of risk that you prefer because you can't avoid it.

In order t

ucts have become life saving products for the pharmaceutical companies who doesn’t have many innovative molecules in their product pipeline and have been inc

make money, you should be a little worried. Because if you're not worried, you're not risking enough. Adventure is part of what make

easingly used in the product life cycle management. Even the companies having product patents are trying to extend their product life cycle through the combi

s life worth living. So don't be afraid to take risks. In fact, if you want to get rich, taking calculated risks is absolutely necess

nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically

ary.

Don't invest in a way that makes you feel comfortable. If you play for meaningful stakes you're going to be worried. Someone sa

and physically. They need to rightly judge the benefits of the combination products and they have to even look at the risks involved when combining the produ

d that worry is the hot and tart sauce of life. Once you get used to it, you can actually enjoy it. If you're not at least a little w

ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi

orried, you're probably not risking enough.

Of course, playing for meaningful stakes does not mean that you should be reckless and i

ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.

Following aspects would a

gnore sound money management principles. It simply means that it's hard to become a successful investor if you're making small bets i

dd to the challenges in developing combination products:

Which markets to tap where the combination products can do fairly well?
Which combination prod

order to sleep better at night. You have to risk enough for it to be meaningful but you also have to preserve your capital if you wa

cts are meaningful and rational?
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin

nt to stay in the game.

And don't over diversify -- the kind of diversification that is recommended by many financial planners who s

tions increase the patient compliance?
What would be the developing cost?
How to tackle the risks encountered during combination product developmen

ay to put a little money here, and a little over there, and a little somewhere else, until you're spread out all over the place. You

t?

As combination products don't fit into the traditional categories of drugs, medical devices, or biological products, the USFDA is in the process of devel

ay not lose much, but you're not going to become a successful investor either. Over diversifying also means that it is tough to get r

ping new procedures for reviewing their safety, efficacy and quality.

Professional from academic institutions, pharmaceutical industries, health care indust

ich in bonds, CD's, and other fixed income investments.

Conventional wisdom says to not put all your eggs in one basket. But my expe

y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products

rience is that truly successful people do the opposite -- they put all their eggs in one basket and watch that basket like a hawk.

S

.

As there is an increasing trend of the combination products companies manufacturing such products should be able to tackle the problems involved in the de

to achieve financial freedom, take risks. Make it meaningful -- meaningful enough that you'll may be a little worried. But you'll be

elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

Companies that provide selfless information through particip

living life to the fullest. And, who knows, you may end up being very successful.

And, above all, enjoy the journey.

Copyright 200

tion in industry events and feedback to regulatory authorities would be able to face the challenges and will be successful in developing combination products

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